nd you will need to give yourself a second injection right after the first. Repeat Steps 1–5 using a new syringe. Choose a different site for the second injection.
Step 6: Dispose of the needles and syringes.
Do not re-use a syringe or needle.
To avoid needle-stick injuries, do not recap a needle.
Put your needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
made of heavy-duty plastic
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
upright and stable during use
leak-resistant,
and properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
Throw away the vial into the container where you put the syringes and needles.
If you have any questions, talk to your doctor or pharmacist.
Keep STELARA and all medicines out of the reach of children.
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued 11/2016
© 2012, 2016 Janssen Biotech, Inc.
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 45 mg/0.5 mL Vial Carton
Single-dose vial–
Discard unused portion
NDC 57894-060-02
Stelara®
(ustekinumab)
Injection
45 mg/0.5 mL
For subcutaneous use
Each vial contains 0.5 mL
Information for use and dosage–
See package insert
Rx only
ATTENTION: Dispense the enclosed
Medication Guide to each patient.
Principle Display Panel - 45 mg/0.5 mL Vial Carton
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 90 mg/mL Syringe Carton
Stelara®
(ustekinumab)
Injection
90 mg/mL
For subcutaneous use
NDC 57894-061-03
Contains one 90 mg/mL syringe
Single dose prefilled syringe –
Discard unused portion
See package insert for dosing information
Rx only
ATTENTION: Dispense the enclosed Medication Guide
to each patient.
Principle Display Panel - 90 mg/mL Syringe Carton
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PRINCIPAL DISPLAY PANEL - 130 MG/26 ML VIAL CARTON
NDC 57894-054-27
Single-Dose vial
Discard unused portion
Stelara®
(ustekinumab)
Injection
130 mg/26 mL
(5 mg/mL)
For Intravenous Infusion Only
Must be diluted
ATTENTION: Dispense
the enclosed Medication
Guide to each patient.
Rx only
janssen
PRINCIPAL DISPLAY PANEL - 130 mg/26 mL Vial Carton
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INGREDIENTS AND APPEARANCE
STELARA
ustekinumab injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Sourc |